Family and Childhood Development: The Next Generation ('Kizazi Kijacho')
NCT ID: NCT05598970
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3585 participants
INTERVENTIONAL
2022-09-26
2024-06-05
Brief Summary
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Detailed Description
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Within each of the HD catchment areas in the Control group, one village (in rural areas) or one 'mtaa' (in urban areas) served by the HD and where at least one officially registered CHW is available to work will be randomly sampled. For the 88 Parenting HDs and the 89 UCT only HDs, all villages/mtaas (with at least one available officially registered CHW) will be included in their catchment area to become part of the study. In total, that will give 390 study villages/mtaas in the study sample.
Within each of the selected study villages/mtaas, one CHW will be selected whose catchment area will become the geographic area of interest, i.e., the study community. The study community can be the entire village, a hamlet (sub-village) or an mtaa, depending on the size of the CHW's catchment area. This gives a total of 82 Control communities, 155 Parenting communities, and 155 UCT communities in the study.
Within the Parenting and UCT only study groups, then second layer of randomisation will be done. In the Parenting group (154 communities across 88 HDs), communities will be randomly assigned, stratified by HD, to either one of the following two treatment arms: (i) Parenting only (77 communities) and (ii) Parenting+UCT (77 communities) where the Parenting Intervention will be delivered along with a bi-monthly unconditional mobile money transfer of 77,000 TZS (33 USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). In the UCT only group (155 communities across 89 HDs), study communities will be randomly assigned, stratified by HDs, to either one of two treatment arms: (i) UCT only fixed amount (80 communities) where families will receive a fixed bi-monthly cash transfers each of 109,000 TZS (47 USD) over a period of 15 months (7 transfers in total) and (ii) UCT only vary amount where 77 communities will be randomly allocated to one of the following bi-monthly UCT amounts: 32,000 TZS (14 USD), 77,000 TZS (33 USD), 109,000 TZS (47 USD) over a period of 15 months (7 transfers in total). In each of these two study arms, further randomisation will be done whether the mobile money transfer is given to the father/spouse or the mother.
10 eligible women per community will de randomly sampled to participate in the study, except the bi-monthly UCT vary amount group, where only 5 eligible women per community will be randomly sampled.
Such a design allows to assess the relative cost-effectiveness of the Parenting and/or UCT only fixed amount interventions, and indeed provide insights into the value of adding a parenting component to a social protection program such as the Tanzania Social Action Fund (TASAF).
Additionally, the study will also explore CHW performance, quality of care delivered and other fidelity indicators to analyse impacts based on implementation effectiveness.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Control
This group will serve as the Control group (81 HDs, 81 communities, 810 households) to identify the effects of a Parenting only, Unconditional Cash Transfer (UCT) only, and Parenting+UCT interventions. Caregivers will continue benefiting from a traditional government CHW home visit program, focusing on maternal and child health and nutrition, which is currently in practice in Tanzania.
No interventions assigned to this group
Parenting only
88 HDs, 77 communities, 770 households. Existing CHWs will be trained to use an innovative digital application for the delivery of integrated ECD services to mothers who are at least 20 weeks pregnant and less than 32 weeks pregnant for a period of 15 months. CHWs will provide tailored ECD services (e.g., prompting messages tailored to child age and triggering follow-up visits conditional on changing conditions), covering all aspects of the Nurturing Care Framework (Health, Nutrition, Responsive Caregiving, Early Learning, Safety and Security (WHO, UNICEF, World Bank Group, 2018)). Real time data will be recorded by the CHWs in each visit using the application. Data will include information on visit attendance, activities conducted, home environment, caregiver practices, and CHW observations. From when the target child is 6 months old, group sessions will be organised by CHWs, focusing on caregiver-child interaction and stimulation activities.
Digital application supported CHW Parenting Intervention
All pregnant women served by the trained CHW will be invited to participate in the Parenting program, from when the mother is at least 20 weeks pregnant and less than 32 weeks pregnant with the target child for a period of 15 months. CHWs will visit pregnant women at least 3 times during their pregnancy and at least 16 times following delivery. In addition to the individual home visits, the CHWs will organise bi-weekly in-community group sessions for children aged 6-12 months and their primary caregivers, focusing on caregiver-child interaction and stimulation activities.
The immediate supervisors Health Care Workers (HCWs) of the CHWs will be trained to closely monitor CHWs activities and progress made. HCWs and CHWs will in turn be supervised and supported by district level Council Health Management Team (CHMT).
Parenting services will be provided to all target children of these eligible caregivers, irrespective of their learning or physical abilities.
Parenting+Unconditional Cash Transfer
88 HDs, 77 communities, 770 households. In addition to the Parenting Intervention, pregnant women in the study sample will receive a bi-monthly unconditional mobile money transfer of 77,000 TZS (33 USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total).
Digital application supported CHW Parenting Intervention
All pregnant women served by the trained CHW will be invited to participate in the Parenting program, from when the mother is at least 20 weeks pregnant and less than 32 weeks pregnant with the target child for a period of 15 months. CHWs will visit pregnant women at least 3 times during their pregnancy and at least 16 times following delivery. In addition to the individual home visits, the CHWs will organise bi-weekly in-community group sessions for children aged 6-12 months and their primary caregivers, focusing on caregiver-child interaction and stimulation activities.
The immediate supervisors Health Care Workers (HCWs) of the CHWs will be trained to closely monitor CHWs activities and progress made. HCWs and CHWs will in turn be supervised and supported by district level Council Health Management Team (CHMT).
Parenting services will be provided to all target children of these eligible caregivers, irrespective of their learning or physical abilities.
Unconditional Cash Transfer Intervention
Families will receive from 5-7 months pregnancy over a period of 15 months a bi-monthly unconditional cash transfer, which equals the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under Tanzania Social Action Fund (TASAF), i.e., Tanzania's National Cash Transfer program.
Unconditional Cash Transfer only fixed amount
89 HDs, 80 communities, 800 households. Households, in addition to the CHWs delivering health and nutrition services as usual, will receive a fixed bi-monthly unconditional mobile money transfer each of 109,000 TZS (47USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). The transfer will be randomly assigned between mothers and fathers/spouses within each community, where in half of the eligible households, mothers will receive the transfer and in the other half, fathers/spouses (or household head where the father/spouse is not available) will receive the transfer.
Unconditional Cash Transfer only Intervention fixed amount
The fixed cost for delivering the Parenting only Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer fixed amount' treatment arm, the transfer will be 109,000 TZS (32,000 TZS + 77,000 TZS).
Unconditional Cash Transfer only vary amount
89 HDs, 75 communities, 375 households. In addition to the previous four main treatment arms, there is another UCT only treatment study group where the level of the cash amount varies across communities. Communities, in addition to the CHWs delivering health and nutrition services as usual, in this group will be randomised to receive one of the bi-monthly unconditional mobile money transfer amounts: 32,000 TZS (14USD), 77,000 TZS (33USD), 109,000 TZS (47USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). The transfers will be randomly assigned between mothers and fathers/spouses within each community, where in half of the eligible households, mothers will receive the transfer and in the other half, fathers/spouses (or household head where the father/spouse is not available) will receive the transfer.
Unconditional Cash Transfer only Intervention vary amount
The rationale for the levels of the varying UCT amounts is to keep them comparable with i) the bi-monthly cost of the parenting program per family, ii) the bi-monthly cash transfers disbursed under TASAF, and iii) the sum of the bi-monthly cost of the parenting program and the bi-monthly cash transfer disbursed under TASAF. The fixed cost for delivering the Parenting Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer only vary amount' group, each of the amounts vary individually (32,000 TZS; 77,000 TZS; 109,000 TZS).
Interventions
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Digital application supported CHW Parenting Intervention
All pregnant women served by the trained CHW will be invited to participate in the Parenting program, from when the mother is at least 20 weeks pregnant and less than 32 weeks pregnant with the target child for a period of 15 months. CHWs will visit pregnant women at least 3 times during their pregnancy and at least 16 times following delivery. In addition to the individual home visits, the CHWs will organise bi-weekly in-community group sessions for children aged 6-12 months and their primary caregivers, focusing on caregiver-child interaction and stimulation activities.
The immediate supervisors Health Care Workers (HCWs) of the CHWs will be trained to closely monitor CHWs activities and progress made. HCWs and CHWs will in turn be supervised and supported by district level Council Health Management Team (CHMT).
Parenting services will be provided to all target children of these eligible caregivers, irrespective of their learning or physical abilities.
Unconditional Cash Transfer only Intervention fixed amount
The fixed cost for delivering the Parenting only Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer fixed amount' treatment arm, the transfer will be 109,000 TZS (32,000 TZS + 77,000 TZS).
Unconditional Cash Transfer Intervention
Families will receive from 5-7 months pregnancy over a period of 15 months a bi-monthly unconditional cash transfer, which equals the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under Tanzania Social Action Fund (TASAF), i.e., Tanzania's National Cash Transfer program.
Unconditional Cash Transfer only Intervention vary amount
The rationale for the levels of the varying UCT amounts is to keep them comparable with i) the bi-monthly cost of the parenting program per family, ii) the bi-monthly cash transfers disbursed under TASAF, and iii) the sum of the bi-monthly cost of the parenting program and the bi-monthly cash transfer disbursed under TASAF. The fixed cost for delivering the Parenting Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer only vary amount' group, each of the amounts vary individually (32,000 TZS; 77,000 TZS; 109,000 TZS).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* If the pregnancy does not result in a live birth after enrolment, the respondent will be excluded from the study at the time of endline survey.
18 Years
FEMALE
Yes
Sponsors
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EDI Global
UNKNOWN
Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
UNKNOWN
D-Tree International
UNKNOWN
Ifakara Health Institute (IHI)
UNKNOWN
Yale University
OTHER
University of Chile
OTHER
NHH-Norwegian School of Economics
UNKNOWN
Chr. Michelsen Institute
UNKNOWN
Stockholm University
OTHER
Responsible Party
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Ingvild Almås
Professor
Locations
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Dodoma
Dodoma, Dodoma, Tanzania
Countries
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References
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McCoy, D.C., Marcus W., and Günther F., "Measuring early childhood development at a global scale: Evidence from the Caregiver-Reported Early Development Instruments," Early Childhood Research Quarterly, 10 2018, 45, 58-68.
Jackson-Maldonado D. MacArthur-Bates Communicative Development Inventories. The Encyclopedia of Applied Linguistics. 2012 Nov 5.
World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. World Health Organization; 2006.
Griffiths RB, Wheeler JC. Critical points in multicomponent systems. Physical Review A. 1970 Sep 1;2(3):1047.
Kariger P, Frongillo EA, Engle P, Britto PM, Sywulka SM, Menon P. Indicators of family care for development for use in multicountry surveys. J Health Popul Nutr. 2012 Dec;30(4):472-86. doi: 10.3329/jhpn.v30i4.13417.
Bradley, R. H, "The HOME environment," in Marc H. Bornstein, ed., Handbook of Cultural Development Science, New York: Psychology Press, 2014, pp. 505-530.
Bornstein, M. H., Tamis-LeMonda, C. S., Pascual, L., Haynes, O. M., Painter, K., Galperín, C., & Pêcheux, M.-G. Ideas about parenting in Argentina, France, and the United States. International Journal of Behavioral Development, 1996, 19, 347-367. https://doi.org/10.1177/016502549601900207
Bayley, N., Bayley scales of infant and toddler development. PsychCorp., Pearson, 2006.
World Health Organization, United Nations Children's Fund, World Bank Group. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO. https://apps.who.int/iris/bitstream/handle/10665/272603/9789241514064-eng.pdf
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-01356-01
Identifier Type: -
Identifier Source: org_study_id